Certara is the largest and most comprehensive provider of biosimulation (modeling and simulation), strategic pharmacometrics, and regulatory writing consulting services. Our multidisciplinary team works alongside clients to inform key drug development decisions and expedite the processes around achieving regulatory milestones.
Certara combines its industry renowned pharmacometric and regulatory consultants with our vast software portfolio to provide services that focus on specific outcomes, therapeutic areas, regulatory milestones, and specific populations.
United States: 1-888-708-7444 or 1-919-852-4685
France: +33 1 56 95 17 10
Germany: +49 89 45 10 300
United Kingdom: +44 (0) 114 292 2322
India: +91 984 500 6625
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Over the past eight years, Certara has performed over 140 modeling projects to support oncology drug development. Under the leadership of Dr. Rene Bruno, Certara has pioneered the development of a Tumor Growth Inhibition (TGI) model to leverage Phase II data to predict Phase III overall survival or progression-free survival. In addition, we have applied a range of modeling techniques to address critical decisions from pre-clinical to late stage clinical for antibodies, proteins and small molecules, such as C-QT modeling, metadata analysis, preclinical to Phase 2 PK and TK analysis, and PBPK modeling and simulation.
Biosimulation technology is a leap forward in bringing safer, more effective medications to cancer patients. Certara Consulting Services can help sponsors optimize dosing, inform drug labels, achieve regulatory compliance, and in some cases, waive clinical trials.